Autologous Skin Fibroblasts for Amputation

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Department of Dermatology at Johns Hopkins University, Baltimore, MDAmputation+2 MoreAutologous Skin Fibroblasts - Biological
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether injecting skin cells from the palm or sole can thicken the skin layer at the site of an amputation below the knee, in order to improve healing.

Eligible Conditions
  • Amputation
  • Stem Cells
  • Dermabrasion

Treatment Effectiveness

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 12 months

12 months
Safety as assessed by number of hospitalizations
Baseline, 1 month
Change in amount of skin breakdown as assessed by ulceration measurement

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Autologous skin fibroblasts
1 of 2
Control
1 of 2

Experimental Treatment

Non-Treatment Group

50 Total Participants · 2 Treatment Groups

Primary Treatment: Autologous Skin Fibroblasts · Has Placebo Group · Phase 2

Autologous skin fibroblasts
Biological
Experimental Group · 1 Intervention: Autologous Skin Fibroblasts · Intervention Types: Biological
Control
Biological
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,092 Previous Clinical Trials
31,769,250 Total Patients Enrolled
Luis Garza, MD PhDPrincipal InvestigatorJohns Hopkins University

Eligibility Criteria

Age 18 - 65 · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Both males and females can participate.
You must have had your leg amputated below the knee.
You have been using a prosthetic for at least 3 months, or have had a prosthetic surgically attached to your body for at least 1 month.

Frequently Asked Questions

Is this trial enrolling participants currently?

"According to the clinicaltrials.gov data, this experiment is still seeking participants and has been open since September 5th 2019, with its last revision on June 8th 2022." - Anonymous Online Contributor

Unverified Answer

Has the FDA provided clearance for Autologous Skin Fibroblasts?

"As this is a Phase 2 trial, the safety of Autologous Skin Fibroblasts has been provisionally evaluated at a score of two due to limited evidence on efficacy." - Anonymous Online Contributor

Unverified Answer

Are participants who are of an advanced age being enrolled in this research?

"This clinical trial outlines that patients aged 18 to 65 are eligible for inclusion. For those younger than 18 and older than 65, there exists 3 other trials tailored towards their age ranges." - Anonymous Online Contributor

Unverified Answer

Am I eligible to partake in this experiment?

"This clinical trial is enrolling 50 individuals, aged 18 and 65 who have had amputations. To qualify for the research study patients must also fulfill these requirements: demonstrate a negative pregnancy test at screening, be male or female between 18-65 years old with below-knee amputation; use a prosthetic device possess 3 months of experience or undergone osteo-integration of a prosthetic one month prior to entry into the trial; agree not to become pregnant/breastfeed during their participation and 1 month after completion; adhere to all scheduled visits, biopsy/injection procedures, wound care instructions treatment plan, and other related" - Anonymous Online Contributor

Unverified Answer

How many individuals are partaking in this experiment?

"Affirmative. The records on clinicaltrials.gov demonstrate that this medical trial, which was originally published on September 5th 2019, is actively recruiting participants. A total of 50 individuals are needed to be recruited from 1 site in order for the study to move forward." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.